Zelinared

Package Leaflet: Information for the User

Zelinared, 5 mg, Film-Coated Tablets

Apixaban

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed to you specifically. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What is Zelinared and what is it used for
• 2. Important information before taking Zelinared
• 3. How to take Zelinared
• 4. Possible side effects
• 5. How to store Zelinared
• 6. Package contents and other information

1. What is Zelinared and what is it used for

Zelinared contains the active substance apixaban and belongs to a group of so-called anticoagulant medications. This medication helps prevent blood clots by blocking factor Xa, an essential element in the blood clotting process.

Zelinared is used in adults:

• to prevent blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and move to the brain, leading to a stroke, or to other organs, hindering blood flow to these organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• to treat blood clots in the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Zelinared is used in children from 28 days to less than 18 years of age to treat and prevent the recurrence of blood clots in the veins or blood vessels of the lungs. The recommended dose, adjusted for body weight, is found in section 3.

2. Important information before taking Zelinared

When not to take Zelinared

• if the patient is allergic to apixaban or any of the other ingredients of this medication (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has a liver disease that increases the risk of severe bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recent bleeding into the brain),
• if the patient has a liver disease that leads to an increased risk of bleeding (hepatic coagulopathy),
• if the patient is taking medications that prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in situations where the anticoagulant treatment is changed, when the patient has a venous or arterial access line and heparin is administered through this line to maintain its patency or when the patient is undergoing catheter ablation (a catheter is inserted into their vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions

Before starting treatment, the patient should discuss the following conditions with their doctor, pharmacist, or nurse:

• increased risk of bleeding, such as:
• bleeding disorders, including those that result in decreased platelet activity,
• very high blood pressure that is not controlled with medication,
• if the patient is over 75 years old,
• if the patient's body weight is 60 kg or less,
• severe kidney disease or if the patient is on dialysis,
• liver disease or a history of liver disease.
• This medication should be used with caution in patients with signs of liver dysfunction.
• if the patient has a prosthetic heart valve,
• if the doctor determines that the patient's blood pressure is unstable or if other treatment or surgery is planned to remove a blood clot from the lungs.

When to exercise special caution when taking Zelinared

• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether to change the treatment.

In case of surgery or a procedure that may cause bleeding, the doctor may ask the patient to temporarily stop taking this medication for a short time. If there is any uncertainty about whether a procedure may cause bleeding, the patient should ask their doctor.

Children and adolescents

This medication is not recommended for children and adolescents with a body weight below 35 kg.

Zelinared and other medications

The patient should inform their doctor, pharmacist, or nurse about all medications they are currently taking or have recently taken, as well as any medications they plan to take. Some medications may enhance the effect of Zelinared, while others may weaken its effect. The doctor will decide whether the patient should receive Zelinared while taking other medications and how closely they should be monitored.

The following medications may enhance the effect of Zelinared and increase the risk of unwanted bleeding:

• certain medications used to treat fungal infections (e.g., ketoconazole and others)
• certain antiviral medications used to treat HIV/AIDS (e.g., ritonavir)
• other medications used to reduce blood clotting (e.g., enoxaparin and others)
• anti-inflammatory or pain-relieving medications (e.g., acetylsalicylic acid or naproxen), especially if the patient is over 75 years old and taking acetylsalicylic acid, which may increase the risk of unwanted bleeding
• medications used to treat high blood pressure or heart disease (e.g., diltiazem)
• antidepressant medications called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors.

The following medications may reduce the ability of Zelinared to prevent blood clot formation:

• medications used to prevent seizures or convulsions (e.g., phenytoin and others)
• St. John's Wort (a herbal supplement used for depression)
• medications used to treat tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before taking this medication. The effect of Zelinared on pregnancy and the unborn child is unknown. This medication should not be taken during pregnancy. If the patient becomes pregnant while taking this medication, they should immediately contact their doctor. It is not known whether Zelinared passes into breast milk. Before taking this medication while breastfeeding, the patient should consult their doctor, pharmacist, or nurse. The patient may be advised to stop breastfeeding or stop/avoid taking this medication.

Driving and using machines

It has not been established whether Zelinared affects the ability to drive or use machines.

Zelinared contains lactose (a type of sugar) and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medication. The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Zelinared

This medication should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

Dose

The tablet should be swallowed with water. Zelinared can be taken with or without food. To achieve the best treatment results, the patient should try to take the tablets at the same time every day. If the patient has difficulty swallowing the tablets whole, they should discuss other ways of taking Zelinared with their doctor. The tablet can be crushed just before administration and mixed with water or a 5% aqueous glucose solution, juice, or apple sauce.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the entire powder to a suitable container and then mix it with a small amount (e.g., 30 mL or 2 tablespoons) of water or another liquid mentioned above to prepare a mixture.
• Swallow (drink) the resulting mixture.
• Rinse the pestle and mortar used to crush the tablets and the container with a small amount of water or another liquid (e.g., 30 mL) and then swallow (drink) the rinse liquid.

If necessary, the doctor may administer a crushed Zelinared tablet mixed with 60 mL of water or a 5% aqueous glucose solution through a nasogastric tube.

Zelinared should be taken as directed in the following indications:

Prevention of blood clot formation in the heart in patients with irregular heartbeat and at least one additional risk factor. The recommended dose is one 5 mg Zelinared tablet twice daily. The recommended dose is one 2.5 mg Zelinared tablet twice daily if: the patient has severe kidney impairment, or two or more of the following conditions are met: the patient's blood test results indicate decreased kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or higher), the patient is 80 years old or older, or the patient's body weight is 60 kg or less.

• severe kidney impairment,
• two or more of the following conditions are met:
• the patient's blood test results indicate decreased kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or higher),
• the patient is 80 years old or older,
• the patient's body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one tablet in the morning and one in the evening. The doctor will decide how long to continue treatment. Treatment of blood clots in the legs and blood clots in the lungs. The recommended dose is two 5 mg Zelinared tablets twice daily for the first 7 days, for example, two tablets in the morning and two in the evening. After 7 days, the recommended dose is one 5 mg Zelinared tablet twice daily, for example, one tablet in the morning and one in the evening. Prevention of recurrence of blood clots after completing 6 months of treatment. The recommended dose is one 2.5 mg Zelinared tablet twice daily, for example, one tablet in the morning and one in the evening. The doctor will decide how long to continue treatment.

Use in children and adolescents

Treatment and prevention of recurrence of blood clots in the veins or blood vessels of the lungs. This medication should always be taken or administered as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse. To achieve the best treatment results, the dose should be taken or administered at the same time every day. The dose of Zelinared is based on body weight and will be calculated by the doctor. The recommended dose for children and adolescents with a body weight of at least 35 kg is two 5 mg Zelinared tablets twice daily for the first 7 days, for example, two tablets in the morning and two in the evening. After 7 days, the recommended dose is one 5 mg Zelinared tablet twice daily, for example, one tablet in the morning and one in the evening. For parents and caregivers: it is essential to observe the child to ensure they have taken the full dose. It is crucial to follow the scheduled doctor's visits, as the dose may need to be adjusted with changes in the patient's body weight.

The doctor may change the anticoagulant treatment as follows:

• Switching from Zelinared to other anticoagulant medicationsThe patient should stop taking Zelinared. Anticoagulant treatment (e.g., heparin) should be started at the time of the scheduled intake of the next Zelinared tablet.
• Switching from other anticoagulant medications to ZelinaredThe patient should stop taking the other anticoagulant medications. Zelinared treatment should be started at the time of the scheduled intake of the next dose of the other anticoagulant medication and then continued as usual.
• Switching from treatment with a vitamin K antagonist (e.g., warfarin) to ZelinaredThe patient should stop taking the vitamin K antagonist. The doctor will order blood tests and inform the patient when to start taking Zelinared.
• Switching from Zelinared to treatment with a vitamin K antagonist (e.g., warfarin)If the doctor advises the patient to start taking a vitamin K antagonist, they should continue taking Zelinared for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor will order blood tests and inform the patient when to stop taking Zelinared.

Patients undergoing cardioversion

Patients with irregular heartbeat who require cardioversion to restore a normal heart rhythm should take this medication at the times specified by their doctor to prevent blood clot formation in the brain and other blood vessels.

Taking a higher dose of Zelinared than recommended

If the patient has taken a higher dose of this medication than recommended, they should immediately inform their doctor. The patient should take the medication packaging with them, even if it is empty. If the patient has taken a higher dose of Zelinared than recommended, they may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Zelinared

• If the patient misses a morning dose, they should take it as soon as they remember and can take it together with the evening dose.
• If the patient misses an evening dose, they can take it only on the same evening. The patient should not take two doses the next morning instead; they should continue taking the medication the next day as directed, twice daily.

In case of doubts about taking the medication or missing more than one dose

The patient should consult their doctor, pharmacist, or nurse.

Stopping Zelinared treatment

The patient should not stop taking this medication without consulting their doctor, as stopping Zelinared treatment prematurely may increase the risk of blood clot formation. In case of any further doubts about taking this medication, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Zelinared can cause side effects, although not everybody gets them. The most common overall side effect of this medication is bleeding, which can be life-threatening and may require immediate medical attention. The following side effects may occur when taking Zelinared to prevent blood clot formation in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• into the eyes;
• into the stomach or intestines;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• bruising and swelling;
• Anemia, which can cause fatigue or pallor;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Nausea (vomiting);
• Abnormal blood test results, which may indicate:
• increased gamma-glutamyltransferase (GGT) activity.

Uncommon side effects (may affect up to 1 in 100 people)

• Bleeding:
• into the brain or spinal cord;
• into the mouth or throat, or blood in sputum when coughing;
• into the abdominal cavity or retroperitoneal space;
• from the uterus;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• from hemorrhoids;
• blood in the stool or urine, detected by laboratory tests;
• Decreased platelet count, which can affect blood clotting;
• Abnormal blood test results, which may indicate:
• liver dysfunction;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, as well as difficulty breathing. If any of these symptoms are observed, the patient should immediately contact their doctor.

Rare side effects (may affect up to 1 in 1000 people)

• Bleeding:
• into the lungs or throat;
• into the muscles.

Frequency not known (cannot be estimated from the available data)

• Bleeding:
• into the abdominal cavity or retroperitoneal space;
• into the stomach;
• into the eyes;
• into the mouth or throat, or blood in sputum when coughing;
• into the brain or spinal cord;
• into the lungs;
• into the muscles;
• Skin rash, which can form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, round, red patches under the skin surface, or bruising;
• Abnormal blood test results, which may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• blood in the stool or urine.

The following side effects may occur when taking Zelinared to treat or prevent the recurrence of blood clots in the legs and lungs.

Common side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• from the nose;
• from the gums;
• blood in the urine;
• bruising and swelling;
• from the stomach, intestines, or rectum;
• from the uterus;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count, which can affect blood clotting;
• Nausea (vomiting);
• Skin rash;
• Abnormal blood test results, which may indicate:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) activity.

Uncommon side effects (may affect up to 1 in 100 people)

• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Bleeding:
• into the eyes;
• into the mouth or throat, or blood in sputum when coughing;
• blood in the stool;
• abnormal blood test results indicating blood in the stool or urine;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• from hemorrhoids;
• into the muscles;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, as well as difficulty breathing. If any of these symptoms are observed, the patient should immediately contact their doctor;
• Abnormal blood test results, which may indicate:
• liver dysfunction;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1000 people)

• Bleeding:
• into the brain or spinal cord;
• into the lungs.

Frequency not known (cannot be estimated from the available data)

• Bleeding:
• into the abdominal cavity or retroperitoneal space;
• Skin rash, which can form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, round, red patches under the skin surface, or bruising.

Additional side effects in children and adolescents. If any of the following symptoms are observed, the patient should immediately inform their doctor:

• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling, as well as difficulty breathing. The frequency of these side effects is "common" (may affect up to 1 in 10 people).

Generally, the side effects observed in children and adolescents treated with Zelinared were similar to those in adults and were mostly mild to moderate. Side effects that occurred more frequently in children and adolescents were nosebleeds and unusual vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

• Bleeding, including:
• from the uterus;
• from the nose.

Common side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• from the gums;
• blood in the urine;
• bruising and swelling;
• from the intestines or rectum;
• blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• Hair loss;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count, which can affect blood clotting;
• Nausea (vomiting);
• Skin rash;
• Itching;
• Low blood pressure, which can cause fainting or rapid heartbeat in children;
• Abnormal blood test results, which may indicate:
• liver dysfunction;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (ALT) activity.

Frequency not known (cannot be estimated from the available data)

• Bleeding:
• into the abdominal cavity or retroperitoneal space;
• into the stomach;
• into the eyes;
• into the mouth or throat, or blood in sputum when coughing;
• into the brain or spinal cord;
• into the lungs;
• into the muscles;
• Skin rash, which can form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, round, red patches under the skin surface, or bruising;
• Abnormal blood test results, which may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• blood in the stool or urine.

Reporting side effects

If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych: Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of this medication.

5. How to store Zelinared

The medication should be stored out of sight and reach of children. Do not use this medication after the expiration date stated on the carton and blister pack after EXP. The expiration date refers to the last day of the month stated. There are no special storage instructions for this medication. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Zelinared contains

• The active substance is apixaban. Each tablet contains 5 mg of apixaban.
• Other ingredients are:
• Tablet core: lactose, microcrystalline cellulose (microcrystalline cellulose and silicon dioxide), croscarmellose sodium, sodium lauryl sulfate, magnesium stearate (E470b)
• Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172).

See section 2 "Zelinared contains lactose (a type of sugar) and sodium"

What Zelinared looks like and contents of the pack

Pink to dark pink, round, biconvex, film-coated tablets. Tablet dimensions: diameter approximately 8.0 mm, height approximately 3.6 mm. Zelinared is available in cartons containing 6 blisters of 10 tablets each.

Marketing authorization holder

Farmak International Sp. z o.o. ul. Koszykowa 65 00-667 Warszawa tel. +48 22 822 93 06

Importer

Farmak International Sp. z o.o. ul. Chełmżyńska 249 04-458 Warszawa

This medication is authorized in the European Economic Area member states under the following names:

Czech Republic, Estonia, Poland, Slovakia: Zelinared Date of last revision of the package leaflet:May 2025